| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| The study will involve healthy children. |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing neither the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b, nor the 3 pertussis antibody titres as measured at 42 days following vaccination. |
|
| E.2.2 | Secondary objectives of the trial |
To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination when administered to healthy children 12 to 23 months of age, by Infanrix® hexa primary series schedule and for all data pooled.
To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age, by Infanrix® hexa primary series schedule and for all data pooled. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Healthy subject of either gender,
2. Age from 12 to 23 months [from the 12th month birthday to 1 day prior to the 24th month birthday],
3. Negative clinical history of measles, mumps, rubella, varicella and zoster,
4. For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion,
For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion,
5. Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study,
6. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
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|
| E.4 | Principal exclusion criteria |
1. Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
2. Any recent (<or=30 days) exposure to measles, mumps, rubella, varicella and/or zoster involving:
a. continuous household contact, or
b. playmate contact (generally >1 hour of play indoors), or
c. hospital contact (in same 2- to 4-bed room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject), or
d. in the case of varicella, contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery,
3. Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa,
4. Any recent (<or= 3 days) history of febrile illness (rectal temperature >or= 38.0°C),
5. Any severe chronic disease,
6. Active untreated tuberculosis,
7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
8. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems,
9. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
10. Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin,
11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (>or= 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (>or= 2 mg/kg/day prednisone equivalent or >or= 20 mg/day if weight more than 10kg) within the previous 30 days] or other immunosuppressive therapy,
12. Any recent (<or= 2 days) tuberculin test or scheduled tuberculin test through Visit 2,
13. Any previous (<or= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2,
14. Any recent (<or= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2,
15. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives,
16. Any recent (<or= 30 days) participation or scheduled participation in any other clinical trial through Visit 2.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary immunogenicity criteria are the response rates to measles, mumps, rubella and varicella in Group 1 and Group 2 and to hepatitis B and Haemophilus influenzae type b in Group 1 and Group 3 and the antibody titres to the 3 pertussis antigens in Group 1 and Group 3 as follows:
• The response rate for measles defined as the percentage of subjects with measles antibody titres ³ 255 mIU/mL in subjects whose baseline (BS1) measles antibody titre is < 255 mIU/mL,
• The response rate for mumps defined as the percentage of subjects with mumps antibody titres ³ 10 ELISA Ab units/mL in subjects whose baseline (BS1) mumps antibody titre is < 10 ELISA Ab units/mL,
• The response rate for rubella defined as the percentage of subjects with rubella antibody titres ³ 10 IU/mL in subjects whose baseline (BS1) rubella antibody titre is < 10 IU/mL,
• The response rate for varicella defined as the percentage of subjects with varicella antibody titres ³ 5 gpELISA units/mL in subjects whose baseline (BS1) varicella antibody titre is < 1.25 gpELISA units/mL,
• The response rate for hepatitis B defined as the percentage of subjects with antibody titres (anti-HBs) ³ 10 mIU/mL,
• The response rate for Haemophilus influenzae type b defined as the percentage of subjects with antibody titres (anti-PRP) ³ 1.0 μg/mL.
• The post-vaccination GMT to pertussis (anti-PT, anti-FHA and anti-PRN),
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|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Immunogenicity and safety of concomitant versus separate administration of Proquad and Infanrix hexa |
|
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 50 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 60 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the trial will be the last visit of the last subject. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 5 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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